The following data is part of a premarket notification filed by Welmed Inc. with the FDA for Welmed Hypodermic Syringe.
| Device ID | K070936 |
| 510k Number | K070936 |
| Device Name: | WELMED HYPODERMIC SYRINGE |
| Classification | Syringe, Piston |
| Applicant | WELMED INC. 15637 FOX COVE CIRCLE Moseley, VA 23120 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves WELMED INC. 15637 FOX COVE CIRCLE Moseley, VA 23120 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-03 |
| Decision Date | 2007-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849296013505 | K070936 | 000 |
| 00849296013352 | K070936 | 000 |
| 00849296013369 | K070936 | 000 |
| 00849296013376 | K070936 | 000 |
| 00849296013383 | K070936 | 000 |
| 00849296013390 | K070936 | 000 |
| 00849296013406 | K070936 | 000 |
| 00849296013413 | K070936 | 000 |
| 00849296013420 | K070936 | 000 |
| 00849296013437 | K070936 | 000 |
| 00849296013444 | K070936 | 000 |
| 00849296013451 | K070936 | 000 |
| 00849296013468 | K070936 | 000 |
| 00849296013475 | K070936 | 000 |
| 00849296013482 | K070936 | 000 |
| 00849296013499 | K070936 | 000 |
| 00849296013345 | K070936 | 000 |